Low back pain

Grand Rounds July 11, 2025: Novel Approaches to Recruiting Clinical Sites for Embedded Pragmatic Clinical Trials: Insights from the AIM-Back Trial (Trevor Lentz, PT, PhD and Tyler Cope, PT, DPT, ACT)

Posted on by terren.green@duke.edu

Speakers

Trevor Lentz, PT, PhD
Tyler Cope, PT, DPT, ACT
Duke Clinical Research Institute
Duke Department of Population Health Sciences
Durham Veterans Administration

Keywords

AIM-Back; Clinical site recruitment; Cluster randomized trial; Low back pain; Recruitment funnel

Key Points

  • Low back pain is an impactful condition that is more common in the veteran population. Typical low back pain care involves imaging and pharmacologic treatments that don’t always resolve pain issues and may lead to more invasive injection-based or surgical measures that often don’t result in better outcomes.
  • Research has shown that non-drug treatments (eg, cognitive behavioral therapy [CBT], yoga, physical therapy [PT]) are effective but not often used.
  • The AIM-Back trial (Improving Veteran Access to Integrated Management of Back Pain), an embedded pragmatic cluster randomized trial, sought to restructure care practices in Veteran’s Administration (VA) healthcare systems to promote and facilitate 2 clinical non-drug pathways that are supported by established guidelines as first-line treatment for low back pain.
  • Two care pathways were developed in coordination with VA clinicians, veterans, and care givers: (1) Sequenced Care Pathway – This pathway provided an initial onsite physical therapy evaluation and treatment session followed by weekly telehealth physical activity training for 6 weeks. The patient then saw the physical therapist again and was either discharged or provided with 6 weeks of training in psychologically-informed practices to help patients manage pain. (2) Pain Navigator Pathway – In this pathway, a local site clinician who was trained by the study team as a pain navigator discussed and facilitated alternative treatments for low back pain (eg, PT, yoga, CBT, massage). Patient follow up at both 6 and 12 weeks assessed progress and outcomes.
  • AIM-Back used a novel and intentional recruitment method, borrowing the concept of the business sales funnel, to generate as many site leads as possible. The recruitment process was systematic involving a 3 step framework: (1) Identify leads, (2) Approach leads, (3) Engage and select sites.
  • In step 1, leads were identified through Warm Market methods (sites known to the researchers), by Leveraging Data (evaluating lists of providers for potential fit), and through traditional Promotional Outreach efforts (advertising through networks and listservs). AIM-Back identified 184 leads from 53 VA healthcare systems.
  • Step 2 involved approaching leads through email messages. AIM-Back learned that promoting the trial in a way that helps clinicians solve their problems instead of asking clinicians to help with the research was more likely to yield the site. AIM-Back received responses from 23 VA healthcare systems.
  • In step 3, AIM-Back engaged personnel at all levels, from leadership to clinicians, to assess feasibility and buy-in at the site. AIM-Back selected 19 participant sites within 10 VA healthcare systems.
  • The Promotional Outreach strategy proved most effective with 9 (47.4%) of sites resulting from this strategy. The Leveraging Data strategy netted 6 (31.6%) sites, and 4 (21.1%) sites came from the Warm Market strategy. Site recruitment took approximately 3.6-3.8 months on average.
  • 17 sites enrolled 1817 Veterans with most sites (n=16) meeting or exceeding the minimum enrollment goal. When sites chose not to participate, they cited a reluctance to change their existing programs, a lack of clinicians or resources, or they were already participating in similar trials.

Discussion Themes

AIM-Back messaging evolved over the course of recruitment from a more traditional trial marketing email to an email that was more personal, short, and leveraged the standing of Duke University. This more personal approach to recruitment led to better relationships with sites during the trial.

Project management software can be helpful for tracking follow up with site leads and communication during the recruitment process.

One overall goal of AIM-Back was to set up a new clinical program that could continue after the end of the trial. Sites were given training materials for the centralized study components and support from AIM-Back was stepped down slowly. Sites that chose to continue the intervention trained a physical activity/whole health coach and a PT for the psychologically informed PT portion of the intervention.

Indicators of a potentially successful site included qualitative components that reflect a high level of engagement such as high interest and excitement in the study along with a sufficient patient population.

Read more about the AIM-Back trial design.

Grand Rounds January 31, 2025: Advancing Rural Back Pain Outcomes Using Rehabilitation Telehealth (ARBOR-Telehealth): Early Progress and Lessons Learned (Richard L. Skolasky, ScD; Kevin H. McLaughlin, DPT)

Posted on by Sophia Ramirez

Speakers

Richard L. Skolasky, ScD
Professor, Johns Hopkins School of Medicine
Department of Orthopaedic Surgery

Kevin H. McLaughlin, DPT
Assistant Professor, Johns Hopkins School of Medicine
Department of Physical Medicine and Rehabilitation

Keywords

Back Pain; Rural Health; Telehealth

Key Points

  • Low back pain (LBP) is the most common cause of disability globally and in the U.S. It’s the largest driver of U.S. healthcare spending growth and a top non-cancer reason for opioid prescriptions.
  • Physical therapy (PT) is a first-line treatment for LBP. It may include exercise, hands-on interventions, and modalities. These methods are cost-effective and decrease the risk of opioid use and surgery. However, due to barriers around the requisite travel, missed work, etc., only 7 – 13% of patients with LBP attend PT.
  • LBP patients in rural areas, where there are higher rates of opioid use and high-impact chronic pain, attend PT less frequently. PT is less accessible than it is in metropolitan areas; there are up to 40% fewer therapists per person; and the travel distance required to get to a clinic is farther.
  • PT was provided virtually (AKA telerehabilitation) during the pandemic, but the effectiveness of telerehabilitation for chronic LBP is unknown. Notably, not all components of PT can be delivered by video visit.
  • The research team’s aims include examining the effectiveness of risk-informed telerehabilitation in reducing LBP-related disability and comparing the prevalence of opioid use among those receiving telerehabilitation and education at 12 weeks.
  • The team is currently in the enrollment phase. They will begin disseminating their results in September 2028.
  • The research team randomized half the group to risk-informed telerehabilitation and the other half to an educational control group. Both groups received best practice advice through the study website, and the control group received eight video visits with a physical therapist over two months.
  • Community engagement strategies include a patient advisory panel and stakeholder advisory committee made up of physical therapists, primary care providers, and rural and public health advocates.

Discussion Themes

One challenge to flag for future studies is that many patients requested virtual appointments outside of office hours. However, the therapists weren’t able to accommodate these requests.

Another challenge is the inconsistent quality of calls between participants. Most folks have access to a smart device; not everyone has access to a desktop, laptop, or tablet, which are preferred for video calls. To address this, the research team is sending participants a phone stand in advance. They also provide basic exercise equipment, including resistance bands and a yoga mat.

While some patients feel a lack of connection with their therapists via telerehabilitation, others have reported that they felt the connection was stronger given the one-on-one nature of the appointments.

August 22, 2022: IMPACt-LBP Awarded Continuation to Implementation Phase

Posted on by Damon Seils

IMPACt-LBP investigatorsThe NIH Pragmatic Trials Collaboratory is pleased to announce that the IMPACt-LBP NIH Collaboratory Trial received approval this month to transition from the planning phase to the implementation phase. This pragmatic clinical trial embedded in healthcare systems is studying implementation of guideline-based care for low back pain, a leading cause of ambulatory care visits in the United States.

Congratulations to the IMPACt-LBP investigators and their study teams for reaching this important milestone!

IMPACt-LBP will evaluate implementation of the American College of Physicians guideline for low back pain, which involves multidisciplinary collaborative care that includes doctors of chiropractic and physical therapists. The study will measure the effects of first-contact patient referral to these clinicians on physical function, pain, opioid prescriptions, and other patient-level outcomes.

Logo for the IMPACt-LBP NIH Collaboratory TrialThe study is administered by the National Center for Complementary and Integrative Health with additional support from the National Institute of Arthritis and Musculoskeletal and Skin Diseases and the National Institute of Child Health and Human Development. The project is led by Drs. Christine Goertz, Adam Goode, and Hrishikesh Chakraborty of Duke University and Dr. Jon Lurie of Dartmouth Hitchcock Medical Center.

Learn more about IMPACt-LBP.

October 21, 2021: NIH Collaboratory Launches IMPACt-LBP NIH Collaboratory Trial

Posted on by Karen Staman

IMPACt-LBP investigatorsThe NIH Collaboratory is excited to announce the addition of a new large-scale pragmatic clinical trial to its portfolio: Implementation of the American College of Physicians Guideline for Low Back Pain (IMPACt‑LBP). Co-led by investigators at the Duke Clinical Research Institute, IMPACt-LBP is a pragmatic, multisite, 2-arm cluster randomized trial that will evaluate the effect of a multidisciplinary collaborative team approach for low back pain (LBP) versus usual care. In the intervention arm, patients with a primary complaint of LBP will be referred to physical therapists and chiropractic doctors—or primary spine practitioners (PSPs)—as first-line providers.

This study aims to determine if initial contact with PSP clinicians will improve physical function, decrease pain, decrease opioid prescriptions, improve patient satisfaction, and decrease costs and utilization of health care services in patients with a primary complaint of LBP, when compared with usual medical care.

NIH Collaboratory Trials are multicenter, pragmatic trials that are embedded in healthcare delivery systems to gather real-world evidence and answer clinical questions of major public health importance. In its first 10 years, the NIH Collaboratory successfully engaged with 21 complex NIH Collaboratory Trials. IMPACt-LBP will join 6 other NIH Collaboratory Trials that focus on pain as part of a broader effort to reduce opioid prescribing and inform policy.

The results from this study will directly inform implementation and policy efforts to improve the quality of pain management for patients suffering from LBP while simultaneously reducing opioid prescriptions, health care costs and utilization of services.

The study is supported within the NIH Collaboratory by the National Center for Complementary and Integrative Health, with additional support from the National Institute of Arthritis and Musculoskeletal and Skin Diseases and the National Institute of Child Health and Human Development.

 

 

November 20, 2018: Upcoming NIH Funding Opportunity Announcements for Pragmatic Trials Address the Opioid Crisis

Posted on by Karen Staman

The NIH has announced an intent to publish new funding opportunity announcements (FOAs) for 5 or more embedded pragmatic clinical trials that address pain management and the opioid crisis. These projects will become part of the NIH Health Care Systems Research Collaboratory as phased UG3/UH3 cooperative research. Both FOAs will be published in early December with applications due as early as February 2019.

The two notices are:

The announcements are part of the NIH Heal (Helping to End Addiction Long-term) Initiative, which was created in April 2018 in an effort to speed scientific solutions for addressing the national opioid public health crisis.

LIRE Pragmatic Clinical Trial Begins Randomization

Posted on by Gina Uhlenbrauck

One of the NIH Collaboratory’s initial NIH Collaboratory Trial, the Lumbar Image Reporting with Epidemiology (LIRE) study, has begun randomization in early April. The LIRE trial is designed to test whether inserting additional epidemiological information into the lumbar spine imaging reports of patients being treated for lower back pain can help both doctors and patients to better understand and interpret the reports. This in turn could help doctors avoid subjecting patients to unnecessary tests and procedures.

LIRE is a cluster randomized trial, which means that instead of randomizing individual patients, whole clinics (one at the Henry Ford Health System in Detroit; one at Group Health Cooperative in Seattle, with more to follow) are randomly assigned to provide either the experimental treatment or the control treatment to patients.

Cluster-randomized trials offer a number of advantages, including the avoidance of certain kinds of bias that can effect the outcome of a study, but they also raise special issues that can require careful consideration.

The principal investigator of the LIRE trial is Dr. Jeffrey Jarvik  of the University of Washington. You can read more about the LIRE trial here.